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XmAb5574

Phase 1

Chronic Lymphocytic Leukemia | Monoclonal antibody | Oncology |Xencor, Inc.|Last Updated: Apr 21, 2014

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment27

FDA Designations

No designations recorded

Clinical trial landscape

XmAb5574 · 1 trial · 2 indications

Phase 1 1
NCT01161511Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic LeukemiaChronic Lymphocytic Leukemia
COMPLETED27 Analytics
PHASE1COMPLETED
Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia
Chronic Lymphocytic LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the dose limiting toxicities
28 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALXmAb5574

Interventions

NameTypeDescription
XmAb5574BIOLOGICALIntravenous infusion of XmAb5574 administered weekly during two 28-day cycles with an additional dose being administered during the first week of Cycle 1. (Cycle 1 on Days 1, 4, 8, 15, 22; Cycle 2 on Days 1, 8, 15, 22)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * relapsed or refractory CLL/SLL * at least 18 years of age * able to receive outpatient treatment and follow-up at the treating institution * completed all CLL therapies \> 4 weeks prior to first study dose Exclusion Criteria: * previously treated with an anti-CD19 antibody t...

Countries:United States
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Frequently asked questions about XmAb5574

What is XmAb5574 used for?

XmAb5574 is an investigational monoclonal antibody being studied for the treatment of Chronic Lymphocytic Leukemia (CLL). It is being developed by Xencor, Inc. (XNCR) and is currently in Phase 1 clinical development. The drug is intended for patients with CLL, a type of cancer that affects the blood and bone marrow.

Who makes XmAb5574?

XmAb5574 is being developed by Xencor, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol XNCR. Xencor is responsible for the research and clinical development of this investigational monoclonal antibody for the treatment of Chronic Lymphocytic Leukemia.

What phase is XmAb5574 in?

XmAb5574 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and tolerability. The drug is being studied for the treatment of Chronic Lymphocytic Leukemia.

What clinical trials is XmAb5574 in?

XmAb5574 has been studied in one clinical trial with the identifier NCT01161511. This Phase 1 trial, titled 'Safety and Tolerability of XmAb®5574 in Chronic Lymphocytic Leukemia,' has been completed. The study enrolled 27 participants with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma in the United States.

Is XmAb5574 FDA approved?

XmAb5574 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed clinical trial (NCT01161511) was designed to assess the safety and tolerability of the drug in patients with Chronic Lymphocytic Leukemia, but it has not yet received regulatory approval.